Evidence map›Paper›PMID 31033218›Full record

Trial reportJournal of diabetes investigation2019

Long-term safety and efficacy of the sodium-glucose cotransporter 2 inhibitor, tofogliflozin, added on glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week open-label, multicenter, post-marketing clinical study.

Yasuo Terauchi, Hisataka Fujiwara, Yuji Kurihara, Hideki Suganami, Masahiro Tamura, Masayuki Senda, Ryoji Gunji, Kohei Kaku

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of diabetes investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02537834. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02537834 phase4completed

An Open-Label, Multicenter Study to Evaluate 52-Week Long-Term Safety, Tolerability and Efficacy of Tofogliflozin With Glucagon-like Peptide-1(GLP-1) Analogue Treatment In Type 2 Diabetes Mellitus

Ran2015Enrolled65Registered outcomes11Posted comparisons0ConditionsType 2 Diabetes MellitusArmsGLP-1 analogue, Tofogliflozin
Open the trial in the graph
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. The Effects of Imeglimin on Muscle Strength in Patients with Type 2 Diabetes: A Prospective Cohort Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
    Article
  5. Review
  6. Article
  7. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Yasuo TerauchiYokohama City University School of Medicine, Yokohama, Japan.ORCID https://orcid.org/0000-0002-8872-3697
Hisataka FujiwaraPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.ORCID https://orcid.org/0000-0001-9439-9283
Yuji KuriharaPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.ORCID https://orcid.org/0000-0002-3464-0669
Hideki SuganamiClinical Data Science Department, Kowa Company, Ltd., Tokyo, Japan.
Masahiro TamuraPost-Authorization Regulatory Studies, Sanofi K.K., Tokyo, Japan.
Masayuki SendaPost-Authorization Regulatory Studies, Sanofi K.K., Tokyo, Japan.ORCID https://orcid.org/0000-0001-6673-1429
Ryoji GunjiPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
Kohei KakuDepartment of Medicine, Kawasaki Medical School, Kurashiki, Japan.ORCID https://orcid.org/0000-0003-1574-0565
Kowa (Japan) · JPSanofi (Japan) · JPKawasaki Medical School · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

AIMS/

introductionTofogliflozin is a potent and highly selective sodium-glucose cotransporter 2 inhibitor that is currently used to treat patients with type 2 diabetes mellitus. The aim of the present study was to evaluate the safety and efficacy of tofogliflozin add-on to glucagon-like peptide-1 (GLP-1) receptor agonist monotherapy. MATERIALS AND

methodsIn this 52-week, prospective, multicenter, single arm, post-marketing clinical study, Japanese patients who had already been receiving GLP-1 receptor agonist monotherapy for ≥8 weeks, glycated hemoglobin ≥7.0 and <10.5%, and body mass index ≥18.5 and <35.0 kg/m

resultsOf the 67 patients enrolled, 63 patients completed the study. Overall, 26 adverse drug reactions occurred in 17 patients (25.4%). Adverse drug reactions with a frequency of two or more patients (3.0%) were constipation, thirst, dehydration and pollakiuria. Hypoglycemia (n = 1) was limited. With the addition of tofogliflozin to GLP-1 receptor agonist, the subsequent mean (standard deviation) reduction in glycated hemoglobin was -0.6% (1.0%; P < 0.0001). Fasting plasma glucose, bodyweight and blood pressure were significantly improved.

conclusionsTofogliflozin add-on to GLP-1 receptor agonist monotherapy is an effective treatment option with an acceptable safety profile.

Indexed as

Glucagon-Like Peptide-1 Receptor AgonistsAdultAgedBenzhydryl CompoundsBiomarkersBlood GlucoseDiabetes Mellitus, Type 2Drug CombinationsFemaleFollow-Up StudiesGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsMaleMarketing6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triolBenzhydryl CompoundsBiomarkersBlood GlucoseDrug CombinationsGlucagon-Like Peptide-1 Receptor AgonistsGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsSodium-Glucose Transporter 2 InhibitorsGlucagon-like peptide-1 receptorSodium-glucose cotransporter 2 inhibitorType 2 diabetes mellitus

Identifiers

PMID31033218
PMCPMC6825952
OpenAlexW2943285543

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.